The purpose of this study is to test the clinical and laboratory observations of IVIG therapy in the highly sensitized patient. We will study the effects of patients treated with IVIG or Cytogam in combination with plasmaphoresis to modulate the immune response in highly sensitized patients. The goal is to convert a positive crossmatch to a compatible crossmatch that would allow living related transplant to take place or to shorten time on the transplant waiting list.

Intravenous immunoglobulin for: patients who do not have a living donor, have a PRA greater than 30% for 3 consecutive months, and have one positive crossmatch with a cadaveric donor while on kidney transplant waiting list

Drug: intravenous immune globulin

0.5-2 gm/kg monthly (maximum dose of 140 gm/dose) x 4 treatments

Group 2 intravenous immune globulin

Intravenous immune globulin for patients who have living donors with positive crossmatch results.

Drug: intravenous immune globulin

0.5-2 gm/kg monthly (maximum dose of 140 gm/dose) x 4 treatments

Detailed Description:

The purpose of this study is to test the clinical and laboratory observations of IVIG therapy in the highly sensitized patient. We will study the effects of patients treated with IVIG or Cytogam in combination with plasmaphoresis to modulate the immune response in highly sensitized patients. There are two arms in the study, one in which IVIG is administered to patients who have living donors with positive crossmatch results, and another in which intravenous immune globulin is administered to patients with no living donor and have a PRA greater than 30% for 3 consecutive months and a crossmatch with a cadaveric donor while on kidney transplant waiting list. The goal is to convert a positive crossmatch to a compatible crossmatch that would allow living related transplant to take place or to shorten time on the transplant waiting list.

Eligibility

Ages Eligible for Study:

12 Years to 80 Years (Child, Adult, Senior)

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

12 years of age or older

diagnosed with end stage renal disease

currently receiving either hemodialysis or peritoneal dialysis

active on the kidney or kidney/pancreas transplant list

medical clearance of the kidney donor if live related transplant

elevated panel reactive antibody (PRA) greater that 30% for 3 consecutive monthly tests and one positive crossmatch with a cadaveric donor while on the transplant waiting list

Exclusion Criteria:

received IVIG within 6 months prior to enrollment

HIV positive

Positive Hepatitis Be-antigen and/or hepatitis B viral DNA

Selective IgA deficiency or known antibodies to IgA

Allergy to human immune globulin

Pregnant or breast feeding

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00586716